1. Field of the Invention
The invention relates to face-lifting devices. More specifically, however, this application and those co-pending perform face-lifting via precise uniform planar tissue separation with tissue tightening resulting from energetic alteration of the freshly divided tissue planes. The device acts below the surface of the skin through the most minimal of incisions. The invention is the only tip configuration able to generate over 1000 sqcm of wall-less undermined facial skin in under 20 minutes using only three 1 cm long incision. Although, the invention can dramatically and uniformly affect large subsurface areas and volumes of tissue, the device would be considered as minimally invasive cosmetic surgery since the clinically visible incisions are relatively small and recovery period relatively rapid. The invention also pertains to attendant methods for enhancing the energetic effects of the divided tissue planes via concurrent application of organic and inorganic, chemicals and materials. The goal of this application and related applications is to, with minimal invasion and complete epidermal avoidance, efficiently and uniformly separate and divide human tissue planes without leaving remnant fibrous tissue tunnels, to concomitantly coagulate distant unseen blood vessels, and to energetically alter tissues on either side of the said divided tissue planes thereby to induce tissue contraction and strengthening via collagen formation. Additionally, a unique and important side-benefit of the complete and efficient separation of human facial tissue planes (without leaving remnant fibrous tissue tunnels) is to interfere with the reformation of targeted wrinkles, undulations, folds or defects in the surface tissues of the face via undercutting their deep fibrous attachments.
2. Description of Related Art
Animal and human skin is usually composed of at least 3 layers. These layers include the: outermost surface epidermis which contains pigment cells and pores, the dermis or leather layer, and the subdermis which is usually fat, fibrous tissue or muscle. The current target of most rejuvenation methods' energies is the dermis which is comprised mostly of fibroblast cells. Fibroblasts produce a bed of collagen and ground substances such as hyaluronic acid for the dermis. When a disturbance occurs in the dermis such as trauma, fibroblasts are activated and not only produce new reparative strengthening collagen but contract, thus tightening and sealing healing tissue. Collagen is a basic structural protein found through almost all of the human body. It is present in under 5% of the epidermis, half of the dermis and about 20% of the subcutaneous depending upon the race, location, age and previous trauma of the individual. Immediate collagen shrinkage is usually parallel to the axis of the individual collagen fiber which roughly corresponds to the direction of collagenous strands as seen when stained and viewed microscopically. Thermal damage to collagen is likely brought about by hydrolysis of cross-linked collagen molecules and reformation of hydrogen bonds resulting in loss of portions or all of the characteristic collagen triple-helix. New collagen formed as the result of trauma and some diseases; new collagen is technically scar tissue. Nonetheless, a controlled and uniform formation of scar tissue can be medically beneficial and visually desirable as can be seen in cases of previously sun-damaged women's faces following a deep chemical peel. Thus, the formation of new collagen in a desirable, uniform and controlled fashion may lead to tissue strengthening as well as tightening. “ . . . In the human face, without uniformity there is only deformity.”
Currently, a need exists for a surgical device with the following assets: 1) minimally invasive insertion—to treat the entire face and neck through only three ⅜ of an inch incisions, 2a) precise horizontal/tangential tissue layer separation without leaving remnant fibrous (collagenous) tissue tunnels, yet preserving nerve and vessel layered networks while maintaining straight horizontal tracking to break any and all fibrous bonds holding the dermis to deeper structures [seen on the surface as visible wrinkles, folds, crevices], 2b) cutting tip energy application—to coagulate blood vessels located too far from the minimal incisions to be visible the naked eye since use of endoscopes is cumbersome and time-consuming, 3) direct subsurface tissue energy application capability to alter, induce or stimulate fibroblasts/collagen resulting in skin tightening and strengthening thus completely bypassing the ultra-sensitive and fragile epidermis and thus avoiding visible surface scaring and pigment loss/excess.
Applicant meets the following needs: 1) minimally invasive surgery with very few visible surgical device entrance wounds, 2) rapid patient recovery and healing, 3) ability to be used with tumescent anesthesia, 4) complete epidermal avoidance or bypass, 5) 20 minute operating time in the face and neck to efficiently separate and divide human tissue planes, while coagulating blood vessels, 6) concurrent ability to alter tissues adjacent to the divided tissue planes thereby inducing collagenous reformation, contraction and strengthening, 7) complete breaking and detachment of all of the fibrous binding elements between the dermis and the deeper skin structures so that reformation and reattachment will not occur thus reducing the chance that targeted wrinkles, undulations, folds or defects in the surface tissues of the face will reappear following the contractile healing phase. Currently no device or method in the medical literature addresses all of these concerns simultaneously. After the insertion of simple tumescent anesthesia, a human facial procedure is estimated to take only 15 minutes to perform in experienced hands, including stitching.
Cutting (in surgery), lysis (in surgery), sharp undermining and blunt undermining have been defined in applicant's prior related art. Sharp instrument undermining is a mainstay of plastic surgery, however even experienced plastic surgeons performing face-lifts may, from time to time, “lose” the correct tissue plane while performing sharp undermining; even with great skill and experience, previous surgical scarring or aberrant anatomy may thwart surgical perfection during sharp scissor or scalpel tissue dissection/undermining. Blunt undermining employs a rounded, non-sharp tipped, instrument or even human finger to find the path of least resistance between tissues; once the desired plane is found by the surgeon, blunt dissection offers the benefit of a reduced chance to traumatize or damage vital structures such as facial blood vessels or nerves (to facial muscles) thereby reducing the chances for bleeding or permanent facial paralysis. Unfortunately, blunt undermining alone between highly fibrous tissues that exists in the human face results in irregular tunnels with thick fibrous walls.
Disadvantages of the current face-rejuvenating techniques using LASERS are described in the aforementioned referenced patents and those of applicant. Current face-lifting instruments that cut with other than manual energy are incapable of providing a uniform wall free tissue plane during energized face-lifting dissection. Current lasers must be crudely fired from positions outside the patient to energize tissue within the face and cut in a very imprecise fashion (See “Manual of Tumescent Liposculpture and Laser Cosmetic Surgery” by Cook, R. C. and Cook, K. K., Lippincott, Williams, and Wilkins, Philadelphia ISBN: 0-7817-1987-9, 1999) using current energy assisted face-lifting methods. Currently deep dermal tissue is treated, altered or damaged with little precision. Complications from the aforementioned technique have been summarized by Jacobs et al. in Dermatologic Surgery 26: 625-632, 2000.
Disadvantages of the current face-lifting techniques using electrosurgical devices have been defined in the referenced patents and those of applicant.
The paper-thin layer of the skin that gives all humans their pigmentary color and texture is the epidermis. Unfortunately, virtually every skin rejuvenation system that has existed until now (with the exception of injectable skin filling compounds) and even traditional face-lifting surgery (when cutting through the skin around the ear is considered) must pass through the epidermis to attempt to reach and treat the dermis. Damage to the epidermis and its component structures often results in undesirable colorations or color losses to the skin as is seen in scarring. The prime consideration over the last decade for scientists and engineers regarding skin rejuvenation procedures is how to spare damage to the thin but critical epidermis and adjoining upper dermal layer.
This patent application will serve as the first submitted report that significant trauma to a tissue plane adjacent the dermis such, as the subcutaneous (fatty) layer, can induce the opposing overlying layer of dermis to contract, presumably due to inflammatory mediators or cells crossing between the planes. Additionally, the orderly and precise formation of new collagen (neocollagenesis) in the dermis by the invention and related patents may lead to desirable tissue strengthening as well as tightening. As the human facial skin ages, some of the strongest layers of tissue which plastic surgeons use to stitch-tighten the face, the fibrous layers known as fascia or SMAS=Superficial Musculo Aponeurotic System, become thinner and weaker. Disease and environmental factors such as diet and chemical exposure also take their toll. Various embodiments of the invention can be passed along these layers activating fibroblasts, increasing the amount of collagen as a result of the precisely delivered traumatic or tissue-altering energies the device inflicts to the uniform tissue planes the device creates, thus thickening and strengthening the aging layers. If even further strengthening is needed in the giant, precise, bloodless subsurface plane that the device establishes using only three minimally invasive 1 cm incisions, then three minimal incisions allow for the introduction into the face of reinforcing meshes, tethers, slings made of organic and/or inorganic materials as well as facial implants. Prolotherapy agents have never been previously described for facial tightening or strengthening, to our knowledge, possibly because there is currently no instrument available to precisely create uniform facial tissue planes upon which the chemical gradients' of potential prolotherapy agents can act. Following applicants uniform invention-induced facial tissue plane formations, prolotherapy fluids can be injected into the minimal incisions to enhance the actions of the instant device or to cause their own primary effect.
Externally applied Fractional Photothermolysis is distinguishable from this invention and related art. Fractional Photothermolysis (FP) is well described in a most recent publication by Rox Anderson: “Fractional Photothermolysis: A New Concept for Cutaneous Remodeling Using Microscopic Patterns of Thermal Injury” published in Lasers in Surgery and Medicine, volume 34, pages 424-438, 2004 by Manstein D, Herron S, Tanner H, and Anderson R. Anderson states “There is an increasing demand for an effective and safe laser treatment that repairs photo-aged skin. Two treatment modalities, ablative skin resurfacing (ASR), and non-ablative dermal remodeling (NDR), have been developed to address this demand. All currently available laser treatments, however, exhibit significant problems and these laser systems typically operate safely and effectively only over a narrow, patient dependent treatment range.” The prime reason for the narrow range is the ultra-delicate epidermis. Anderson advocates, “Studies indicate that the efficacy for treatment of rhytides (wrinkles) and solar elastosis improves with increased thermal damage depth [Anderson's reference 9]. The most effective Erbium:YAG (Yttrium Aluminum Garnet) lasers for the treatment of rhytides use longer pulse durations to increase the residual thermal damage depth [ref 10]. To enhance wound healing without sacrificing efficacy, a combined approach has become popular for ASR [ref 11]. To overcome the problems associated with ASR procedures, the so-called NDR technologies have emerged that selectively damage the dermal tissue to induce a wound response, but avoid damage to the epidermis [refs 12-25]. In this technique, controlled dermal heating without epidermal damage is achieved by combination of laser treatment with properly timed superficial skin cooling. The wound response to thermally damaged dermal tissue results in formation of new dermal collagen and repair of tissue defects related to photoaging. The absence of epidermal damage in NDR techniques significantly decrease the severity and duration of treatment related side effects. Lasers used for NDR procedures have a much deeper optical penetration depth that superficially absorbed ablative Erbium:YAG and CO2 lasers. While it has been demonstrated that these techniques can avoid epidermal damage, the major drawback of these techniques is limited efficacy [ref 26]. Anderson measures and reports a mere 2% tissue shrinkage results: “ . . . small but reproducible, skin shrinkage was observed as measured by microtattoo placement. Skin shrinkage was still evident 3 months following treatment . . . ” Anderson's concern to minimize permanent epidermal damage, especially in darker-skinned patients, is evident “In our study, there were several dark-skinned subjects, who demonstrated little or no significant pigmentation abnormalities after FP at low or medium MTZ (Microscopic Treatment Zones) densities per treatment. Histology revealed that there is a localized, well-controlled melanin release and transport mechanism using MENDs (Micro Epidermal Necrotic Debris) as a ‘vehicle’.”
Externally applied FP as described by Anderson differs from applicant. Anderson's FP device must be placed on the external skin surface and has not been described for internal use to reach the outer layers of skin from the inside route. Anderson's FP device is external, not designed to, not can it, break the fibrous tissues beneath the surface skin and cannot be passed beneath the skin without another attachment or device such as applicant's tip to “ice-break” the way. Without breaking the fibrous bonds below the skin surface that attach the surface skin to the deeper structures of the face that bind wrinkles in permanently. Unfortunately, surface treatments are only temporary and cause only minor tightening. Anderson's externally applied art must restrict energy delivery which renders only a 2% tightening in order to avoid damaging the fragile epidermis. Anderson uses MENDs (Micro Epidermal Necrotic Debris) that allow sufficient time and space for traumatic epidermal re-growth to occur to avoid permanently damaging the epidermis. An embodiment of applicant creates MEND or even Focal Macroscopic Necrosis (FMN) and delivers energy, from inside out on uniform tissue planes allowing uniform energy gradients and therefore bypass the delicate and sensitive epidermis while still bringing about deeper tissue contraction. Applicant's U.S. Pat. No. 6,203,540 involves laser fiberoptics which can be pulsed and delivered below the skin to bring about FMN like lesions. Fiber sizes mentioned would provide energy destruction patterns greater in size then MEND's; however, fiberoptic size in U.S. Pat. No. 6,203,540 may be reduced to bring about damage volumes somewhat greater than or approaching the size of MENDs and discharge more energy ‘upward’ toward the epidermis than Anderson for greater dermal alteration with minimized epidermal effect. Applicant allows for the treatment of a larger surface area much more rapidly because of the capability for greater direct, internal energy transfer. Applicant treats the entire face and neck to the collarbones in under 20 minutes operating time by an experienced hand. Anderson's device delivers only a 2% tissue contraction measurement in tissue under no growing tension as compared with applicant's 20%-30% contraction in 10×10 sqcm tattoo grids on the abdomens of baby pigs that doubled in size over the 3 month study period (unpublished, photographs available upon request). The difference in results is largely due to the great disparity between the two methods in energy delivered to the tissues. (Underlining was added for emphasis).
Laser treated tissues and electrosurgically treated tissues are similar in several respects. However most importantly, when it comes to internally electro-modifying human tissues, is that immediately local vaporized tissue regions take on a relatively high electrical impedance, and increase the voltage difference, thus altering further local electrical penetration/treatment of the tissues. Irregular energy absorption by irregularly thick and irregularly formed fibrous tunnel remnants resulting from the use of devices, other than applicant's, would thus cause visible irregular skin surface effects on healing. Other reasons why applying tissue-altering energy to precisely formed facial tissue planes without fibrous tunnel wall remnants is important include: “the electrical impedance of tissue is known to decrease with increasing frequency due to the electrical properties of cell membranes which surround the electrically conductive cellular fluids. As a result of higher tissue impedance, the current flux lines tend to penetrate less deeply resulting in a smaller depth of tissue heating. If greater depths of issue heating are to be effected a higher output voltage and frequency must be used. Lower impedance paths will automatically result in lower resistive heating since heating is proportional to the operating current squared multiplied by impedance.”
Monopolar electrosurgical instruments possess a single active electrode at the tip of an electrosurgical probe. Low voltage applied to the active electrode in contact with the target tissue moves electrical current through the tissue and the patient to a dispersive grounding plate or an indifferent electrode. Voltage differences between the active electrode and the target issue cause an electrical arc to form across the physical gap between the electrode and tissue. At the point of arc contact with tissue, rapid tissue heating occurs due to high current density between the electrode and tissue. Current density causes cellular fluids to vaporize into steam yielding a cutting effect. Monopolar electrosurgery methods generally direct electric current along a defined path from the active instrument electrode through the patient's body into the return or grounding electrode. Small diameter electrodes increase electrical field intensity in the locality. Bipolar configurations more easily control the flow of current around the active region of a treatment device which reduces thermal injury and thus minimizes tissue necrosis and collateral tissue damage while reducing conduction of current through the patient. Applicant believes that the optimum combination of electrical energies to be used in conjunction with a protective tip is monopolar cutting current in the lysing segments and adjunctive monopolar or bipolar coagulation current along the planar aspects of the device. Because of applicant's discovery that the highly resistive lower fatty layer plane of facial dissection may be electrically or energetically traumatized and eventually result in the transfer of mediators into overlying, over-draping dermis causing its contraction (likely by inflammatory chemical mediators or cellular transfer), logically higher energy formats than bipolar would be necessary to necrose the fatty layer for the transfer effect (subcutaneous to dermis traumatic inflammatory shrinkage transfer effect=SDTISTE) to occur.
Eggers in U.S. Pat. No. 5,871,469 and related patents differs from applicant. Eggers teaches an electrosurgical device that requires an ionic fluid to create conduction between minute arrayed electrodes and relies on an ionic fluid source from within the instrument to function optimally. Eggers teaches bipolar energy flows principally between pairs or groups of minute electrodes arranged in various arrays depending upon the embodiment chosen. Unfortunately, observing Eggers' diagram 2c top view may lend the incorrect impression of similarity in shape to the applicant tips; however, in Eggers the protrusions are electrodes/conductors which would irregularly violate and destroy the vital human facial tissue structures including the subdermal plexus of vessels on passage if creation of a plane were attempted or even possible. Applicant's protrusions are non-conductive or insulated protectors and facilitate precise device movement, wall-free uniform tissue plane formation while providing for vital subdermal plexus tissue preservation. Eggers' embodiment of electrode arrays at the tip may be likened to component rasps of a oil well drill bit where the array protrusions bite into and chew away to form a canal in the target tissue, a desired effect that is totally counter to the intentions and dynamics of applicant. To quote Eggers in U.S. Pat. No. 5,871,469 column 4 line 49: “The electric field vaporizes the electrically conductive liquid into a thin layer over at least a portion of the active electrode surface and then ionizes the vapor layer . . . ”. Eggers teaches vaporizing a thin layer of an optimizing conducting fluid; additional application of a conducting fluid is not a necessity for applicant. Eggers furthermore reveals in column 11: “The depth of necrosis (tissue death, lethal alteration) will typically be between 0 to 400 microns and usually 10 to 200 microns (=0.2 mm).” The energy levels that are generated by applicant allows tissue damage to depths of 4 mm (4,000 microns) over twenty times greater than Eggers' safe range. Only applicant can create tunnel free, wall free, uniform tissue planes upon which to apply tissue modifying energy or tissue modifying chemicals and render uniform gradient potential. Eggers' U.S. Pat. No. 5,871,469 external skin resurfacing (Visage®) requires an external ionic fluid drip and has been in clinics and is known not to remove much more than very fine wrinkles without epidermal pigment changes or scarring. Only the thinnest wrinkles can be reduced by Visage®. Eggers fails to describe any protrusion-recession tissue protecting energizable tip to reliably track without the formation of tunnels or remnant tunnel walls capable of creating uniform facial tissue planes upon which to uniformly transfer energy. Without uniform tissue planes to uniformly energize, there will cannot be uniformity of tissue contraction. Without facial uniformity there is only non-uniformity.
Eggers' U.S. Pat. Nos. 6,740,079 and 6,719,754 and 6,659,106 and 6,632,220 and 6,632,193 and 6,623,454 and 6,595,990 and 6,557,559 and 6,557,261 and 6,514,248 and 6,482,201 and 6,461,354 and 6,461,350 are virtually all bipolar in nature and require a fluid delivery element that may be located on the probes or part of a separate instrument. Alternatively, an electrically conducting gel or spray may be applied to the target tissue. All are incapable of yielding tunnel-wall-free, completely uniform facial planes upon which to energetically act thereupon. '559B1 does teach a single platypus-bill shaped, asymmetrically located, “atraumatic” shield which is totally incapable of yielding tunnel-wall-free, completely uniform facial planes upon which to energetically act since a single shield would create non-uniform tunnels and be deflected by them to a zone of least resistance. '354B1 requires that the bipolar electrodes be maintained “a distance of 0.02 to 2 mm from the target tissue during the ablation process . . . maintaining this space . . . translate or rotate the probe transversely relative to the tissue (brushing)”. If coagulation or collagen shrinkage of a deeper region of tissue is necessary (sealing an imbedded blood vessel) . . . press the electrode terminal . . . Joulean heating.” In itself, '354B1 would thus be impossible if not completely impractical device for use as an internal, minimally-invasive, complete facial tissue modification device because fulfilling such requirements of pressing blindly to seal unseen blood vessels up to 10 cm away from a limited incision port would impossible without an endoscope and thus take hours to complete surgery (less than opening up and closing an entire traditional face-lift). The handling of bleeding vessels, as per column 8 of '350B1, is surgically awkward without an endoscope and surgically impossible if performed blindly from limited incisions for the same reasoning as just mentioned for '354B1. '350B1 relies on the relative weakness of the electrical energy found in bipolar designs; circuitry detection and interruption with an alarm may fail to preserve nerves as opposed to applicant which relies on geometry to maintain precise location on motion and palpable feel to manipulate away from known nerve locations to avoid damage. Applicant and other facial surgeons disagree with Eggers statement in '261B2 that 150 degree Centigrade temperatures generated by probe's residual heat can seal vessels; those who disagree cite the example medium sized branches of the facial artery in the event of a bleed a hidden distance from minimally invasive incision sites. In all of Eggers, especially '193B1, FIG. 3, initial inspection of the two-dimensional figures may resemble those of applicant, however the protrusions are in a cylindrical base, conductive, non-insulated, not linearly arranged and do not have a lysing segment between them. '248B1 uses a laterally deployable and retractable antenna arising from the side of a pencil-shaped shroud-like probe to more precisely modify electrosurgical arcs for cutting of tissue. '248B1 differs from applicant by using a laterally based electrode and being unable to position said portion of the cutting instrument for uniform lysis of the delicate undersurface of the face. The lateral wire of '248B1 would be forced in a direction opposite the areas of greatest fibrous build-up adjacent non-uniformly lysed tunnels thus resulting in a non-uniform result. '079B1 is an electrosurgical generator capable of delivering uniform discharge arc at the tip and thus more precise cutting wave. '079B1 uses an active electrode with a dynamic active surface area of varying geometry however, applicant's geometry differs significantly in that '079B1 is incapable of yielding tunnel-wall free completely uniform facial planes which would adversely effect evenness in tissue plane energy absorption. Additionally, the monopolar cutting current of '079B1 is undesirable for collagen/fibrous tissue modification function of applicant's tissue-modifying-energy-window/zone and would largely damage the delicate underside of the facial dermis and dermal plexus since '079B1's stated and anticipated geometry lacks the protective insulated protrusions of applicant to safeguard such vital structures. Virtually all of Eggers teaches bipolar electrosurgery; as Eggers states, bipolar electrosurgery desirably create the following “plasma layer confines the molecular dissociation process to the surface layer to minimize damage and necrosis to the underlying tissues.” To bring about significant uniform and safe modification of the overlying dermal and epidermal tissues without irregular defects such as necrosis is not possible without applicants geometry and adjacent energy function. Because of this lack of significant tightening efficacy without permanent epidermal changes or scarification, Visage® has seen only limited use in cosmetic surgery and salons; use at higher energy levels has caused undesirable surface skin scarring.
Goble, U.S. Pat. No. 6,210,405 teaches an electrosurgical rasping device that works similarly to Eggers. Goble teaches a “rasping” device that creates vapor bubbles requiring aspiration around the targeted tissue as opposed to applicant who teaches smooth forward instrument without rasping to wear down target surface. Goble teaches uses in orthopedic surgery and urological surgery requiring a saline like solution “ . . . to fill and distend the cavity . . . ” as opposed to Applicant and applicant's prior related art which does not. Goble teaches an instrument useful for “brushing . . . debulking . . . sculpturing and smoothing” as opposed to applicant who cuts and passes smoothly by the target tissue which is not to be removed but energetically altered and left in place to remodel. Gobel requires an ionic fluid pump and an aspirator and mentions the need for endoscopic assistance as opposed to applicant. Applicant teaches a feel-only, blindly operated device wherein pumps or aspirators are optional. Goble's teaches “rasping” as acting like a rasp to “wear down” as opposed to applicants prior use of the word “rasp” which just the feeling that the operating surgeon gets when the device passed successfully in the proper fibro-fatty facial tissue plane.
Thermage, Inc. of Hayward, Calif. recently introduced to the market its tissue contraction product of an externally applied electrosurgical template activated while touching the outer. Energy passes through the epidermis thus passing energy through the upper skin with the intention of electrically altering collagen to achieve remodeling; damage to the epidermis is reduced some by externally spraying a cryogen (cooling gas) of about −40° C. on the targeted zone's epidermis at the time of the electrical impulse. Unfortunately, the amount of tissue contraction Thermage, Inc. can prove in the medical literature borders upon statistical insignificance (to quote several prominent cosmetic surgeons) and is far less than 5%. Currently, great debate exists in the cosmetic dermatologic community as to whether a statistically significant improvement exists at all regarding Thermage's tissue contraction. U.S. Pat. No. 6,413,255B1 of Stern relates to Thermage's device and is an externally applied “tissue interface surface . . . and has a variable resistance portion.” '255B1 teaches a linear array of externally applied bi-polar electrodes; an externally applied monopolar embodiment using return electrodes is also illustrated. Base claims in '255B1 regarding the electrosurgical delivery device indicate contact with the skin's external, outer surface. Knowlton U.S. Pat. Nos.: 6,470,216 and 6,461,378 and 6,453,202 and 6,438,424 and 6,430,446 and 6,425,912 and 6,405,090 and 6,387,380 and 6,381,498 and 6,381,497 and 6,337,855 and 6,377,854 and 6,350,276 and 6,311,090 and 6,241,753 and 5,948,011 and 5,919,219 and 5,871,524 and 5,755,753 are Thermage, Inc. licensed. Knowlton mentions in '498B1 “the methods of the present invention do not provide for total necrosis of cells. Instead, . . . a partial denaturization of the collagen permitting it to become tightened.” Knowlton cites the failure of U.S. Pat. No. 5,143,063 to protect the melanocytes (pigment cells of the epidermis) as a need “for tissue tightening without damaging the melanocytes or other epithelial cells, or without surgical intervention.” Knowlton's before-mentioned art is thus classified as non-invasive and therefore involving no incisions or intended openings even in the epidermis as a result of tissue damage. Applicant's art requires incisions as opposed to the before-mentioned art of Knowlton which is not mentioned to be inserted through the skin; Knowlton's devices are far to large to be adapted to any minimally invasive surgical sites. '854B1 Method for Controlled Contraction of Collagen in Fibrous Septae in Subcutaneous Fat is largely viewed in the medical community to be undesirable. Pulling on the septal strings cause in-pocketing of the surface skin. This because cellulite (an undesirable problem) is currently widely thought to be the result of contracted fibrous septae causing in-pocketings of the upper skin layers down toward the fatty layer. In '753B1 Knowlton desires to create no deeper than a second degree burn on the tissue surface to internally scar and thus create tissue contraction over areas such as a bony callus over periosteum and states, “This method is particularly useful in tissue sites that are devoid or deficient in collagen.” In '753B1 Knowlton mentions that the device can be done transcutaneously, percutaneously or via endoscope, Knowlton also mentions reverse thermal gradients in that epidermal sparing results form heating below the surface. The principle of delivering electricity on a medical instrument under the skin is not novel, just the use of Knowlton's specific embodiment is. Similar percutaneous delivery of energy has however long been the practice of surgeons dating for electrosurgery at least from the mid 1980's and for laser surgery from the 1990's when Cook was directing lasers percutaneously to contract the underlying dermis of the neck. Much of the endoscopy art dating over one to two decades allows for percutaneous delivery electrosurgery and or laser. Most distinguishing is that '753B1 fails to provide a means to create a uniform planar tissue surface upon which to deliver electronic energy in a uniform fashion. Irregular target surfaces yield irregular electronic energy gradients. Applicant can provide a uniform band of freshly separated facial tissue to treat that is free of fibrous tunnel walls; thus, the overlying collagen can be uniformly treated by an underlying energy source and gradient without resultant striping or banding of the overlying skin including the epidermis. '753B1 provides no means nor an enablement to allow for a minimally invasive creation of a path in which to pass the '753B1 device freely without the formation of tunnels or breaking strong fibrous impediments. Knowlton in '276B1 displays a FIG. 2A showing an “introducer” that crudely in two dimensions resembles applicant; however, this is merely because the cylindrical 2A device with protruding attachment channels for cables, catheters, guide wires, pull wires, insulated wires, optical fibers, and viewing devices/scopes has been rendered only two-dimensionally whereas three-dimensional considerations reveal great dissimilarity. Knowlton's description in column 4 of '276B1 mentions the device coupling to a template to receive a body structure. '276B1 apparently mentions and designs for only external tissue (or other outer layer skin like mucosa) to be in contact with the template. The remainder of the group of patents are related to '090 and involve externally applied devices to the outer skin with ion permeable porous membranes using electrolytic solutions that at least partially conform over the external skin surface in a way similar to rubber ('202B1 teaches inflating a membrane for body conformation); monopolar and bipolar embodiments are presented. Such devices are intended to pass radiant energy (defined as any kind that can cause cell heating or physical destruction . . . including RF, microwave, ultrasound, etc.) through the epidermis in a uniform fashion and to minimize epidermal damage using cooling lumens and surface cooling fluids. Applicant and applicant's prior related art on the other hand teach an internal probe with a special tip that provides tunnel-free planar lysing precisely through human face while maintaining a tracking feeling. Nonetheless, following many published studies the energy applied through the simultaneously cooled epidermis of US '255B1 is insufficient provide a consensus on photographic wrinkle or tissue tightening improvement beyond mild. Conversely, Applicant and applicant's prior related art teaches energy levels that are much higher in fluence and bypass the ultrasensitive epidermis altogether. Applicant and applicant's prior related art does not necessarily require a cryogen spray to reduce epidermal heating so as to pass significantly greater levels of electrical energy into the targeted dermis.
Brucker, U.S. Pat. No. 5,500,0012 and other spot treatment combination energy devices using laser, fiberoptics, radiofrequency, ultrasonic or microwaves differ from Applicant and applicant's prior related art in their inherent shapes which are usually catheter like, bendable, circular in cross section. Flexible catheters cannot not penetrate the fibrous tissues of the face on their own. Such devices are usually meant to migrate between organs to perform a ‘spot’ treatment on one or more of them. It is to be noted in FIG. 4 of Brucker that electrodes 18 & 20 are detector electrodes meant to aid in the detection of electrical heart arrhythmias and that any similarity to the insulated protruding segments of Applicant and applicant's prior related art is clearly different when two dimensional drawings are considered in three dimensions just as was Eggers'. Brucker as a bendable catheter would not have the rigidity to course along the proper fibrous facial plane and would simply bore a hole or tunnel or be directed in a path of least resistance. The only similarity between Brucker and the instant application of Applicant and applicant's prior related art is that Brucker may carry fluids toxic to heart cells; however, applicant's use of prolotherapy with the device is to uniformly modify a uniformly created tissue plane. The arrays of electrodes in Brucker are detecting electrodes located around the tip of Brucker in which lies a single energized treatment electrode that only escapes or transiently protrudes from the catheter channel when there exists a need to kill heart cells that are improperly firing electrically; Brucker's protruding arrays are usually not deployed in motion and would likely interfere with motion by catching on tissues during motion, Brucker's protrusions therefore do not aid in device motion.
Single lumen, circular or non-planar cross sectional laser delivery devices such as Keller U.S. Pat. No. 5,445,634 & U.S. Pat. No. 5,370,642 usually require the use of an accessory endoscope. An endoscope is a cumbersome optical instrument that would usually requires two hands to use at the same time the surgeon is handling Keller's instrument to direct it to the target tissue which would be difficult indeed. Keller and similar devices differ by lacking applicant's planar tip configuration of protective relatively protruding non-conducting elements with energized relative recessions. Applicant's art can be manipulated blindly by the surgeon without the aid of an endoscope since the device provides instant continuous feedback via a simple palpable “feel” that the surgeon can easily learn and rely on for certainty that the device is migrating in the tissue properly. Devices such as Keller can only perform spot tunneling unless the surgeon is also using an endoscope that focuses some type of tissue dissociating energy along an entire tissue plane; unfortunately, to maintain a coordinated planar movement with Keller would be time-consuming and difficult. Keller discusses that results using '634 and '632 are limited to channels.
Loeb of U.S. Pat. No. 5,984,915 teaches passing only a single bare optical fiber through human facial subcutaneous skin tissue. Loeb however does not teach any housing or rigid or semi-rigid structure that would allow passage of a bare optical fiber through undissected tough and fibrous human fibro-fatty facial tissue. In line 55 column 6 Loeb states and alleges: “The optical fiber is a bare optical fiber . . . The tip pierces the skin and is advanced into the subcutaneous tissue while emitting laser energy . . . ” Loeb further teaches in column 9 line 14: “The diameter of the tip of the optical fiber is in the range of about 25-100 microns (<0.1 millimeter) . . . Preferably about 50 microns . . . ” Those skilled in the art readily know that it is impossible to advance such a thin fiber through relatively impenetrable human facial tissue to have any uniform clinical effect. Without uniformity on the face, one has deformity. In light of the human facial anatomy, where the dermis is composed of almost impenetrable collagen fibers close to the density of football leather and where the subcutaneous fatty layer contains collagenous fibrous septae that are relatively dense although not as dense as the fatty layer of abdomen, Loeb cannot deliver a uniform effect and is impractical as enable in '915. Applicant differs from Loeb because applicant provides for a relatively rigid structure housing energetic elements that can penetrate the extensive fibrous septal network of the facial subcutaneous layer and provide uniform tissue surfaces to enlarge thus altering the collagen of this layer of the face efficiently. Loeb teaches a pulsed energy level in Table 1 for “skin wrinkle removal”, that even if the impossible task of passing a single hair thin optical fiber through the relatively dense facial fatty layer were possible then based upon Loeb's fiber diameter it would take many hours to days to efficiently irradiate or treat a whole face. It is noteworthy that under most facial wrinkles, collagenous accumulations are particularly dense further arguing against Loeb.
The term rhytisector is a compound word derived from (rhyti=wrinkle)+(sector=to cut or remove). The tool was usually inserted under the skin in a natural crease, fold or hairline a distance from the targeted wrinkle to be “removed”. A rhytisector is a “Y” shaped device made of metal with the shaft/base of the Y usually being between 8 cm and 16 cm long and the arms of the V portion of the Y being about 3-4 mm and the base (acute angle) of the rhytisector is usually thin and cutting in nature. Rhytisectors discussed in the medical literature are completely flat when viewed horizontally from the side and not electrified energized in any way. Rhytisector use has decreased dramatically over the last decade. Unfortunately, the rhytisector tool developed a reputation for intense bleeding leading to bruising, hematomas (blood pools) and unwanted blood vessel laceration (breaking open). This was largely due to the sharp edges and no ability to coagulate. Applicant has searched catalogues from prior to 1999 of many major electrosurgical and plastic surgical/medical instrument manufacturers: Bernsco, Ellman, Colorado Biomedical, Conmed, Delasco, Snowden-Pencer, Tiemann, and Wells-Johnson and found no mention of any rhytisector that was electrifiable or substantially electrically resistive on the distal tips of the “Y”. Even if a rhytisector was insulated similar to applicant the shape would be different since the rhytisector is a completely thin and equally flat instrument.
U.S. Pat. No. 5,776,092 by Farin describes a single tube device that can deliver laser, ultrasound or radio frequency devices to treat tissue. However, Farin's device is not intended for separating tissue planes and is susceptible to catching, tearing or puncturing the tissue when manipulated. The dissimilarities between Farin's device and those similar have been described in this application and those co-pending.
The dissimilarities of using ultrasonic liposuction cannulas for face-lifting or facial tightening from this patent application have been described in this application and those co-pending.
There exists a special subset of the general population that may benefit uniquely from the present invention. The facial skin and substructure of Caucasian men and women begins to droop and develop folds between the ages of 45 and 55. Patients of Asian, Hispanic and African origin will experience the same stage of this condition but at a bit later age. Currently long incisions of 10-20 cm are made around each of the two ears, for the purposes of hiding the scars; skin is cut out and discarded and the remaining skin stretched. Unfortunately, skin does not thicken in response to stretching and removal; it only thins. In the early 1990's, some plastic surgeons advocated “prophylactic” or “preemptive” face-lifting on women in their 40's purportedly to “stay ahead of nature.” This philosophy of “prophylactic face-lifting” has now been largely discredited by the vast majority of reputable surgeons.
Given the disadvantages and deficiencies of current face-lifting and skin-tightening techniques, a need exists for a device that provides a fast and safe alternative. The present invention utilizes a unique energized lysing design adjacent to various similar and dissimilar forms of energy to induce tissue contraction. The present invention provides a process for human or animal tissue strengthening to achieve face-lifting, facial tightening, or non-facial tissue tightening. The device and methods can rapidly be used in hospitals as well as office-based surgery and minimizes pain and risk of injury.